Compact non-electric medicament infuser

ABSTRACT

An assembly is provided which includes an infusion device coupled to a standard medication syringe. The medication syringe may be coupled to a stopcock valve having multiple ports and to which syringes, vial adapters, infusion tubing, and multiple other items may be coupled. The infusion device includes a source of power based on a resistance force such as vacuum, spring or gas power. The infusion device converts the resistance based force to usable work in the form of a force applicator. The force applicator includes a driver section on one section of a reciprocating arm and an attachment to the power source on another section of the arm. The driver is pulled outward (excursion) to increase the size of the chamber, creating a force that tends to return the driver back inward, causing incursion. The driver can be attached removably to the syringe plunger to induce the infusion process.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority from International Patent ApplicationNo. PCT/US2012/000550 filed on Nov. 8, 2012.

FIELD OF THE INVENTION

The following invention relates to infusion equipment for deliveringmedicament (medication or other medical preparations) into thebloodstream or other locations within the body of a patient or animal.More particularly, this invention relates to infusion devices which workwith a standard medical syringe to deliver medicament from the syringeover a desired period of time and in a manner which does not requireelectronics or coupling to an external power source for proper function.

BACKGROUND OF THE INVENTION

Many medicaments require infusion into a patient or animal over anextended period of time, rather than in a single immediate dose.Infusion systems are known in the art to allow such medicaments to be soinfused in a controlled fashion over a period of time. Such infusionsystems generally include an intravenous access point where a medicalprofessional has already placed an “IV” into the patient with medicaltubing coupled to a needle penetrating the skin and typically into avein of the patient. Additionally, such infusion systems include someform of reservoir for containing the medicament to be delivered and someform of infusion device for causing the medicament to move along theinfusion tubing and through the IV into the patient.

In perhaps a simplest infusion system, gravity provides the forcerequired by merely placing the reservoir at a height elevated relativeto the IV intravenous access point. Gravity fed infusion systems havelimitations in that the amount of force cannot be readily changed, otherthan through the imprecise method of increasing the elevation of thesupply reservoir.

In other infusion systems an infusion pump is provided which applies aforce on the fluid in the reservoir or along the infusion tubing tocause the fluid to move into the patient at the intravenous access site.One form of infusion pump acts on a medicament containing vessel in theform of a syringe by merely pushing on the plunger of the syringe at itsproximal terminal end to deliver a medical preparation from the syringe.Such infusion pumps generally include some form of complicatedelectromechanical linear displacement transducer which converts anelectric signal from a controller into mechanical motion in the form oflinear motion acting on the plunger, to cause dispensing of the medicalpreparation from the syringe reservoir. The linear displacementtransducer can be in the form of a solenoid type device or in the formof some form of motor, such as a stepper motor acting upon a rack andpinion type gear to convert rotating motion into linear motion. Otherlinear displacement transducers can also be utilized within suchinfusion pumps to convert the electric control signal into mechanicalmotion.

These electronic infusion pumps have the benefit of being able toutilize electrically driven displays and commonly available buttons anddials for thorough control of infusion rates and volumes, but also havesignificant deficiencies including a reliance on their internalmechanisms and a continuous source of electricity. If the power suppliedfrom the AC plug or the DC battery is discontinued, full or partialfailure of the pump may occur, causing incomplete or inaccuratemedication delivery. The pump may also fail with respect to itselectronic or mechanical parts within. These sorts of failures oftenlead to medication errors causing significant patient morbidity andmortality. These complex, expensive pumps increase the cost ofdelivering medical care, are cumbersome to use, require troubleshootingand frequent service. In addition, some magnetic or electric medicalequipment can be interfered with by other equipment containing metal orgenerating electric signals, presenting a need for non-electric and/ornonmetallic infusion devices. These electronic devices cannot be usednear an MRI scanner, but the patients often require ongoing infusion oftheir medicines, therefore a nonmagnetic/non-electronic device would bedesirable.

Accordingly, a need exists for a simple but reliable medicament infusionsystem which utilizes an infusion device that does not require anelectric power supply, can function reliably, and has low cost.

The prior art patents to Yamada (U.S. Pat. No. 5,807,337) and Mitchell(U.S. Pat. No. 5,024,664) demonstrate vacuum powered infusion deviceswith several limitations and have never attained significant clinicaluse. These devices connect the drive section to the syringe/load chambersection, which does not allow for independent operation of the twosections. This deficiency does not allow one to use the syringe sectionto self load by aspiration, nor does it allow one to readily discontinueand/or restart infusion by disengaging or reengaging the drive sectionfrom the medicament containing (syringe-like) section. These devicesrequire the user to obtain and load a separate syringe so they canforcefully inject the desired medicament into the load chamber againstthe vacuum force of the connected drive section through a loading portwhich is occasionally separate from the infusion port. This obviouslyrequires one to measure and load a separate syringe containing themedicament, attach it to the load chamber of the infusion device andapply an undue amount of finger pressure to force the medicament fromthe separate syringe into the load chamber as the user must overcome thevacuum force during this filling procedure. These additional steps, suchas loading one syringe first to inject medicament into another, greatlyincreases the chance of medication error. Another limitation with theseinfusers is the lack of a guide or stabilizer to assure lineartranslation of the plungers during infusion. If the Yamada or Mitchelldevice plungers were significantly extended as with a significantly“full” device, there would be degree of rotation, flex and increased“play” in the apparatus which would allow increased friction andunreliable or nonlinear infusion rates. Another limitation of the Yamadaand Mitchell devices is the difficulty faced with a loss of vacuum. TheMitchell device does not have a port to reestablish a vacuum should itbe lost and the Yamada device has a “plug formed of a resilient materialsuch as rubber” which requires removal in the event the vacuum needs tobe replenished or if one wishes to alter the degree of vacuum force.Manipulation of a rubber plug is cumbersome and time consuming. Anotherlimitation of these devices is the lack of a handle to independentlyoperate the drive section. This deficiency is severely limiting andclearly demonstrates these devices are meant to be loaded withmedicament only through the use of the second syringe as mentionedabove, thereby extending the load chamber and drive section together andnot allowing for independent operation of either section. Thisdeficiency yields an inability to rapidly discontinue, start, or restartmedicament infusion and maintains the load chamber in an alwayspressurized state making any attempt at placing medicament into thedevice cumbersome.

A prior art patent to Minezaki (U.S. Pat. No. 7,041,081) demonstrates avacuum powered infusion device with many limitations. The device rigidlyconnects the drive section to the syringe/load chamber section, whichdoes not allow for independent operation of the two sections. Thesedeficiencies do not allow one to use the syringe section to self load byaspiration, nor does it allow one to readily discontinue and/or restartinfusion by disengaging or reengaging the drive section from themedicament containing section. The device requires the vacuum section tobe cocked back and locked with a “stopper capable of locking the pistonat the rear end of the vacuum pump barrel against atmospheric pressure,”before the two sections are placed together, and requires the vacuumbarrel to be placed “in a state in which the front end of the vacuumpump barrel of said first structure extends further forward than thefront end of the liquid syringe.” One preferred embodiment of thisdevice includes a version with the need for two medicament reservoirsconnected together which is complicated and expensive. A secondpreferred embodiment demonstrates a rigidly aligned coaxial versionwhich does not offer the independent functions required as the twosections are again rigidly connected. Other prior art patents Minezaki(U.S. Pat. No. 6,685,673) and Hiejima (U.S. Pat. No. 6,139,530) alsodemonstrate coaxial mechanisms with similar limitations.

Accordingly, a need still remains for a simple but effectivenon-electric self powered infusion device and system for deliveringmedicament into a patient in a reliable controlled fashion.

SUMMARY OF THE INVENTION

With this invention a medication infuser is provided which is compactand not reliant on electric power, and which includes an infusion deviceas part of an overall infusion assembly which is of a simple nature andyet can reliably deliver medicament from a reservoir into the patient.The overall assembly includes an infusion device coupled lateral to astandard syringe. This coupled arrangement may be reversible where thesyringe is removable or may include a unification of the syringe andinfuser through bonding or molding. A preferred embodiment of theinfusion device includes a chamber within an outer body coupleable tothe medicament containing syringe, such as by way of a clamp. Areciprocating arm is provided which is aligned with a long axis of thechamber to move into and out of the chamber. This arm has a slidingsealed piston on one end and a driver with a handle at the other end.This sliding sealed piston prevents air from passing around the arm andinto a space between the sliding sealed piston and an interior of thechamber. This space can thus reliably hold a vacuum therein to provide aresistance force tending to cause the arm to move into the chamber(incursion) unless sufficient opposing forces are applied. Such opposingforces would include activating the infusion device by pulling out onthe handle (excursion) or resistance by the syringe plunger as it pushesfluid out during infusion.

The reciprocating arm is configured so that it can rotate in a preferredform of this invention. Such rotation allows the driver to engage aplunger of the medicament containing syringe in some orientations and befree of interference with the plunger of the medical preparationcontaining syringe in other orientations. During infusion, the arm isgenerally prevented from rotation or lateral motion so that it providesstable linear force transfer for infusion to the plunger of themedication containing syringe.

The infusion assembly also preferably includes a valve, such as in theform of a stopcock to which the medicament containing syringe is coupledthrough a first port. A second port leads to an intravenous access portor other interface with a patient, typically through a flow rateregulator. The stopcock valve can have other ports, such as a portthrough which medicament is initially supplied for loading of themedicament containing syringe. This medicament can be supplied through asingle port or through multiple ports, such as through a medical vialadapter interface or through a secondary syringe, or through both, suchas when the medication within the vial needs to be measured or mixedwith a diluent material such as saline before being loaded into themedicament delivery syringe.

This stopcock is preferably configured so that it is easily manipulatedbetween different positions to cause flow of the medicament orconstituents thereof in different directions depending on whether themedicament delivery syringe is being loaded or unloaded and whether themedicament is being supplied from a vial or syringe, or is ready to bedelivered to the patient. All parts of the infusion assembly includingthe infusion device operate without requiring electric power or otherelectric systems. Furthermore, such systems do not require a particularorientation relative to gravity for effective operation.

OBJECTS OF THE INVENTION

Accordingly, a primary object of the present invention is to provides aninfusion device which is non-electric.

Another object of the present invention is to provide a medicamentinfusion device which can operate reliably and which is durable forreliable and long-term use.

Another object of the present invention is to provide a medicamentinfuser which is compact in form and easy to set up and operate.

Another object of the present invention is to provide a medicamentinfuser which can be flexibly operated in a variety of different ways,including receiving medical preparations from a variety of differentinitial sources and being readily activated and deactivated for flexibleperformance in accordance with the desires of medical professionals.

Another object of the present invention is to provide a low costmedicament infusion system.

Another object of the present invention is to provide a medicamentinfusion system where at least part of the system is disposable.

Another object of the present invention is to provide a medicamentinfusion system with a lower rate of medication errors.

Another object of the present invention is to provide a medicamentinfusion assembly which can be utilized to accept medicament from avariety of different initial sources, including liquid and powderedpreparations, into a reservoir from which it can be infused into apatient.

Another object of the present invention is to provide an infusionassembly which does not require a particular orientation relative togravity for proper function.

Another object of the present invention is to provide a medicamentinfusion system which is compatible with MRI scanners.

Another object of the present invention is to provide an infusion devicewhich can infuse a medicament from a standard syringe.

Another object of the present invention is to provide an infusion devicewhich can be integrated into a standard type disposable intravenousadministration set.

Another object of the present invention is to provide a medicamentinfuser that may be easily attached to the patient.

Other further objects of the present invention will become apparent froma careful reading of the included drawing figures, the claims anddetailed description of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of the infusion assembly of this inventionand showing the infusion device of this invention ready to be attachedto a medicament containing syringe. Also, the stopcock valve, medicationbottle and associated interface, second syringe coupling to the stopcockvalve and patient interface are shown.

FIGS. 2 and 3 are top plan full sectional views of the stopcock valve ofFIG. 1, showing two different alternative embodiments for orientation ofinternal embedded fluid flow pathways within a manifold hub of thestopcock valve to provide flow as desired within the infusion assembly.

FIG. 4 is a perspective view similar to FIG. 1, but with the infusiondevice having been clamped onto the syringe and with the syringe shownloaded with the medicament and with the infusion device arm and driverready to be rotated into position to drive the plunger of the syringeand deliver the medicament through the infusion assembly into thepatient.

FIGS. 5 and 6 are top plan full section views similar to that which isshown in FIGS. 2 and 3, but for different orientations for the stopcockvalve that correspond with FIG. 4.

FIG. 7 is a perspective view similar to that which is shown in FIGS. 1and 4, but after the infusion device arm and driver has been rotatedinto position to act on the plunger of the syringe, and shown in theprocess of moving the piston to deliver medicament into the patientthrough the infusion assembly.

FIGS. 8 and 9 are top plan full sectional views similar to that which isshown in FIGS. 2, 3, 5 and 6 but for different orientations for themanifold hub of the stopcock valve.

FIG. 10 is a perspective view of the stopcock valve and associatedmanifold hub of this invention, particularly showing an alternativemanifold hub according to an alternative embodiment of this invention.

FIG. 11 is an exploded parts view of that which is shown in FIG. 10.

FIG. 12 is a full sectional view of that which is shown in FIG. 10,taken along lines 12-12 of FIG. 10.

FIG. 13 is a full sectional view of the stopcock valve of FIG. 10, takenalong lines 13-13 of FIG. 10.

FIGS. 14-17 are perspective views of the infusion device of thisinvention showing the various stages in the operation of the infusiondevice of this invention.

FIG. 18 is a full sectional view taken perpendicular to a long axis ofthe infusion device, and particularly showing how the arm of theinfusion device has portions thereof which can rotate freely relative toa faceted alignment guide opposite a distal end of the infusion device,and other positions where such rotation of the arm relative to thealignment guide is prevented.

FIG. 19 is a perspective view similar to FIGS. 1 and 7, but with theinfusion section and the syringe section molded or bonded together as asingle unit.

FIG. 20 is a perspective view similar to FIG. 7, but with a dampeningsystem shown consisting of a dampening cylinder attached to the infusiondevice body and a dampening rod attached to the force activator section(force activator is equivalent to the arm and driver together). Thedampening system becomes active by allowing interaction of the cylinderand rod when the infusion device interacts with the syringe duringinfusion and allows infuser incursion at a controlled, desired infusionrate. The dampening system components (cylinder and rod) may be reversedwith respect to their location.

FIG. 21 is a perspective view similar to FIG. 7, but with the infusiondriver's handle and thrust area oriented differently. Here the thrustarea is positioned on the end of the driver's loop like handle, ratherthan that location shown in the other figures where it is positioned onthe transverse member more near the first bend in the arm. The handleand driver's function is still essentially identical, but there is a“loop” rather than an open “hook” formed by the handle during infusion.

FIG. 22 is a perspective view demonstrating the infusion systemmedicament syringe being integrated into a disposable intravenousadministration set (commonly utilized in the practice of IVadministration which connects the fluid to be infused with the IVcatheter in the patient's vein) where it may accomplish the goals setforth in this disclosure, but with a step saved as it allows theinfusion device to be already integrated into the “intravenousadministration set,” thereby not requiring connection. This arrangementmay allow a solitary integration or it may be placed in the position ofthe “drip chamber” and utilized for both functions (infuser and dripchamber), if so desired by the manufacturer or practitioner. Thisintegration is shown with the syringe in the position of the dripchamber thereby acting as the drip chamber and as a syringe adapted toinfuse. The infuser is positioned lateral to the syringe but notconnected in this figure.

FIG. 23 is a perspective view of an infuser and syringe providedaccording to an alternative embodiment of the invention of thisapplication, featuring a clamp assembly and retainer structure forholding the syringe to the infuser.

FIGS. 24-28 are perspective views of the infuser and syringe of FIG. 23in various different stages of interfacing together, and action of theinfuser upon the syringe to drive fluids out of the syringe according toa method of this invention.

FIG. 29 is an exploded parts view of that which is shown in FIG. 23.

FIG. 30 is a detail of a portion of that which is shown in FIG. 23revealing details of a system featuring one-way biased O-rings.

FIG. 31 is a perspective view of the driver with one-way biased O-ringsshown separated from other portions of the infuser.

FIG. 32 is a perspective view of a pair of infusers and a pair ofsyringes all assembled together illustrating one assembly which can beconfigured utilizing the infuser and syringe of this invention.

FIG. 33 is a perspective view of an alternate infuser which has a clampassembly and retainer structure which are configured to facilitateattachment of three syringes to a single infuser.

FIG. 34 is a perspective view of an alternative embodiment gas driveninfuser and associated syringe.

FIG. 35 is a perspective view of an alternative embodiment motorizedinfuser and syringe.

FIG. 36 is a perspective view of an alternative embodiment torsionspring driven infuser and associated syringe.

DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring to the drawings, wherein like reference numerals representlike parts throughout the various drawing figures, reference numeral 10is directed to an infusion device for use with a syringe S, such aswithin an overall infusion assembly 2 for delivery of medicament overtime from the syringe S into a patient or animal. The infusion device 10utilizes a vacuum or another resistance based force to energize and“activate” the arm 40 and driver 50. The arm 40 and driver 50 togetherare known as the force applicator and when activated, may act upon aplunger P of the syringe S so that a piston J within the syringe S movesto drive the medicament out of the syringe S and to the patient.

In essence, and with particular reference to FIG. 1, basic details ofthis invention are described, according to a preferred embodiment. Theinfusion assembly 2 in this preferred embodiment includes the infusiondevice 10 removably coupleable (along arrow F) to the syringe S. Thesyringe S is coupled to a stopcock valve 60 which has separate portswhich act as inlets or outlets into or out of other portions of theinfusion assembly 2. These ports A, B, C, D can lead to a second syringeT, a vial adapter 90 adapted to receive and assist in removal of amedicament from a medication bottle M, and a patient interface generallyin the form of a regulator 80, a tube 82 and a connector 84. Theregulator 80 may be integrated into the stopcock valve 60, the tube 82,or the connector 84, or may simply be accomplished by having small boretubing 82 of appropriate diameter and length to act as a flow resistanceregulator itself. The stopcock valve 60 includes a housing 62 whichsupports a manifold hub 70 therein. By rotation of the manifold hub 70,different ports A, B, C, D within the stopcock valve 60 are brought intofluid communication with each other for passage of fluid between thealigned ports and equipment coupled to these ports.

In the most preferred embodiment the infusion device 10 includes a body21 around a chamber 20 in which a vacuum can be drawn. This vacuumchamber 20 can be replaced with a spring, gas cylinder or otherresistance force based energizing means. A clamp 30 is coupled to thebody 21 in this embodiment which allows the infusion device 10 to besnapped onto the syringe S, or the syringe S to be snapped into theinfusion device 10 (along arrow F). A reciprocating arm 40 translatesinto and out of the chamber 20 with a sliding sealed piston 42 on aninnermost (distal) end of the arm 40 and a driver 50 on the proximal endof the arm 40 opposite the sliding seal 42. The driver 50 is adapted toengage the proximal terminus H of a plunger P of the syringe S to causethe plunger P to move within the syringe S and cause medicament withinthe syringe S to be delivered therefrom. The arm 40 is rotatable tobring the driver 50 into and out of alignment with the proximal terminusH of the plunger P of the syringe S, for selective engagement anddisengagement of the infusion device 10 by rotation of the arm 40relative to the chamber 20.

More specifically, and with continuing reference to FIG. 1, as well asFIGS. 4 and 7, standard details of the infusion assembly 2 which aregenerally available alone in the prior art are described to provideproper context for understanding of unique details of the infusionassembly 2 of this invention.

The syringe S is most preferably a standard syringe having a generallycylindrical hollow body forming a cylinder and with a plunger Ptranslating into and out of this cylinder of the syringe S. The cylinderincludes a fluid conveyance port typically at a distal end and anopening surrounded by a radially extending ledge R at a proximal endwhich allows the plunger P to pass into and out of the interior of thecylinder. The plunger P includes a proximal terminus H on a proximal endthereof and a piston J on an end of the plunger P opposite the proximalterminus H. The piston J includes seals thereon so that fluid cannotmove around the piston J as the piston J moves within the syringe Scylinder. The fluid conveyance port of the syringe S is adapted to becoupled to one of the ports of the stopcock valve 60. In this exemplaryembodiment, the syringe S is shown with the fluid conveyance portcoupled to port C of the stopcock valve 60. Such a connection can merelybe through a “luer” type fitting or some other type of coupling which ispreferably a coupling which can be removably attached.

Because this syringe is preferably of a standard type, it wouldtypically have graduation lines on a side of the body and associatedindicia representative of volumetric capacity of the syringe S with thepiston J at various different positions within the syringe S. With thesyringe S in the form of a standard syringe in this preferredembodiment, the syringe S can be used in a variety of different waysknown in the art either before or after attachment to the stopcock valve60 (e.g. by utilizing any known technique for loading a syringe S beforeattachment to the stopcock valve 60 and utilization with the infusionassembly 2) or for loading of the syringe S in standard ways through thestopcock valve 60, or for manipulation of the syringe S manually by auser pushing on the plunger P of the syringe S when such manipulation ofthe syringe S is desired by a medical professional.

In addition to the syringe S, a second syringe T can be coupled to oneof the ports. In this embodiment, such a second syringe T is shownattached to port B of the stopcock valve 60. The second syringe T canact as a medicament container, a measuring device or a mixing device,such as for accurately measuring a dose of medication or mixing a salinesolution with a medication to properly measure, mix or dilute amedication contained in syringe T (or syringe S) or in a medication vialattached to another port before transferring the medication into thesyringe S for delivery through the infusion assembly 2 of thisinvention. This capability would give the medical professional theability to dilute a powdered (or liquid) medication attached at anotherport while in place, then dilute it, mix it, measure it, and transfer itto the syringe S for infusion. The second syringe T can also be utilizedfor holding a second volume of like or different medication which couldeither be co-infused along with a first medical preparation within thesyringe S, or to be utilized on an itinerant basis at the direction ofthe medical professional. The second syringe T preferably interfaceswith port B the same way that the syringe S interfaces with port C. Suchsyringes S, T and other components of the infusion assembly 2 can becoupled to any one of the ports A, B, C, D without any particularrequirement that any particular component of the assembly 2 be coupledto any particular port A, B, C, D.

A medication bottle or vial M is known in the prior art which contains amedication and with a septum L often at an interface on the medicationvial through which a needle can pass to draw a medical preparation outof the vial M. In this preferred embodiment, the infusion assembly 2includes a vial adapter 90 with associated needle 92 extending axiallytherein. The vial adapter 90 and needle 92 are preferably coupled to oneof the ports (port A in FIGS. 1, 4 and 7) of the stopcock valve 60. Sucha coupling can be similar to the coupling for attachment of the secondsyringe T or syringe S to the stopcock valve 60 through other ports B,C. Thus, a medication vial M can be inserted into the vial adapter 90and a needle 92 can pierce the septum L of the medication vial M. Themedical preparation (medicament) can then be drawn out of the medicationvial M through the needle 92 and into the stopcock valve 60 for deliveryto any of the other portions of the infusion assembly 2 coupled to thestopcock valve 60.

The vial adapter 90 is available as prior art and typically somewhatcylindrical and open at one end. It is typically long enough to preventor discourage fingers of a medical professional from bumping into thetip of the needle 92. Also, the vial adapter 90 helps to align themedication bottle M with the needle 92 so that the needle 92 canreliably hit the septum L and penetrate the septum L. The vial adapter90 can have different diameters to accommodate different medicationbottle sizes or could otherwise be configured to more flexiblyaccommodate different medication vials M of different sizes while stillproviding some degree of protection from inadvertent contact with theneedle 92.

With these various components of the infusion assembly 2 which are knownin the prior art being able to interface with the stopcock valve 60, theinfusion assembly 2 is provided with equipment that is familiar tomedical professionals so that the operation of the infusion assembly 2is simple and intuitive for the medical professional. Furthermore,flexibility in the interconnection of various medical components is tosome extent facilitated by the interchangeability of the ports in thestopcock valve 60 and the general configuration of the infusion assembly2 which allows for flexible arrangement of different medical equipmentinto the infusion assembly 2.

The fourth port D of the stopcock valve 60 typically is coupled to someform of patient interface, such as through a tubing 82, a regulator 80and a connector 84. The regulator 80 may be a discreet part or may beintegrated into the stopcock 60, tubing 82 or connector 84. Theregulator 80 can act as a fixed or adjustable control for flow ratesinto the patient. If adjustable, it would typically have dials, buttonsor some other manipulatable interface and perhaps a display indicatingits current setting. The tubing 82 is preferably flexible and elongateso that the infusion assembly 2 is not required to be located too closeto the patient. The connector 84 would typically be in the form of amale luer lock adapter, a simple intravenous access needle, or any otherform of prior art connector able to connect into the patient'sintravenous, intraarterial, intraosseous, or other body lumen system asdesired by the medical professional.

With continuing reference to FIGS. 1, 4 and 7 primarily, details of theinfusion device 10 of the infusion assembly 2 are described. While theinfusion device 10 is described in conjunction with the entire infusionassembly 2, it is conceivable that the infusion device 10 could merelybe used with a single syringe S directly coupled to some form of patientinterface without the stopcock valve 60. Furthermore, the infusiondevice 10 could conceivably be utilized for distribution of any fluidfrom the syringe S even in a non-medical environment, such as in alaboratory or industrial setting for timed release of a fluid.Furthermore, the infusion device 10 might be utilized on a syringe S fordelivery of a fluid within some form of manufacturing process wheredelivery of a fluid at a somewhat regular rate over time is required,and where it is desired that the infusion device 10 exhibit thesimplicity and non-electric nature of the infusion device 10 of thisinvention.

The infusion device 10 in this preferred embodiment utilizes an energystorage and resistance force application principle (resistance forceenergizer) that is generally associated with a vacuum within a chamber20 of the infusion device 10. It is known that within the atmosphere andin other environments where a fluid pressure is present, that if avacuum is formed in a particular location that forces are exerted totend to close up this vacuum space. Essentially, in our atmosphere theair within the atmosphere pushes on all walls of the vacuum space to tryto close up this vacuum space. Such a force is utilized by the infusiondevice 10 in this preferred embodiment to provide the force required toact on the syringe S to cause delivery of medicament into the stopcockvalve 60 for operation of the infusion assembly 2 of this invention.

The preferred embodiment infusion device 10 is generally configuredsimilarly to a standard medical syringe. The body 21 and chamber 20 arethus generally cylindrical in form and elongate along a central axis.One end of the chamber 20 is closed defining a distal end 22. Thisdistal end 22 preferably includes a port with a form of closure 24 suchas a cap or an open/close valve. Such a distal port and closure 24 areuseful in that they allow installation of an arm 40 with an associatedsliding sealed piston 42 into the chamber 20 and evacuation of any airor other fluids within the chamber 20 during such installation or suchas to restore the vacuum state within the chamber 20 should it ever belost for any reason (such as removal of the arm 40 or extension of thesliding sealed piston 42 too far out of the chamber 20, causing loss ofthe vacuum state within the chamber 20).

A ported base 26 is provided on the proximal aspect of the infusiondevice body 21 opposite the distal end 22 acts as a proximal end of thechamber 20 which is generally perpendicular to the long axis of the bodyand does retain the sealed piston 42, but is not a fluid tight barrierin the vacuum powered version because atmospheric pressure must reachthe proximal side of the sealed piston to impart its force on the piston(as the vacuum chamber exists on the distal side of the piston). In apreferred embodiment, this ported base 26 includes a faceted alignmentguide 28 which provides an opening through which the arm 40 canreciprocate.

In a most preferred embodiment of this invention this faceted alignmentguide 28 has facets thereon which only allow the arm 40 to translatetherethrough when the arm 40, having matching or corresponding facets46, is properly aligned for passage through the faceted alignment guide28. In other orientations of the arm 40, the faceted alignment guide 28can interact with facets 46 on the arm 40 to prevent arm 40 translationthrough the faceted alignment guide 28 of the ported base 26.

The chamber 20 may be sized larger, smaller or similarly to the syringeS to provide various different degrees of force application and variousdifferent associated infusion rates for the infusion device 10.Typically, the chamber 20 is formed of plastic materials similar tothose from which syringes are typically formed. The contour of thechamber 20 is preferably formed to be amenable to manufacture byinjection molding or similar low cost manufacturing processes so thatthe infusion device 10 can be manufactured in a precision manner at lowcost to desirably provide both robust and low cost performance to theuser.

A clamp 30 is included with the infusion device 10 for attachment of theinfusion device 10 to the syringe S. In this preferred embodiment, theclamp 30 is coupled directly to the body 21 of the infusion device 10.The clamp 30 is elongate in form, and typically having a lengthapproximating the syringe S length. The clamp 30 is attached to the body21 through a joint 32 which is preferably fixed so that the clamp 30does not move relative to the body 21 and may be molded with the body 21as a unit.

The preferred clamp 30 is a semi-cylinder of hollow nature so that ithas an inside wall 34 forming a portion of a cylinder and an outsidewall 36 forming a portion of a cylinder (although shapes other than acylinder could be utilized as an effective clamp). Edges 38 define endsof these walls 34, 36. Preferably, the clamp 30 is slightly more thanhalf of a full cylinder. Thus, the edges 36 extend slightly toward eachother and are closer to each other than a diameter of the cylindricallyshaped clamp 30. The clamp 30 is preferably formed of sufficientlyresilient material that the edges 38 can be flexed away from each otherslightly. This material is also preferably sufficiently elastic that theclamp 30 will apply a clamping force tending to cause the clamp 30 toreturn at least partially back toward an original state and continue tomaintain an inwardly directed clamping force to help the clamp 30securely attach to the syringe S.

Furthermore, the clamp 30 has a proximal end 39 which is preferablysubstantially planar and perpendicular to a long axis of the clamp 30and chamber 20. This proximal end 39 is configured to abut against theledge R at the proximal end of the syringe S. One such ledge R is shownin FIGS. 1, 4 and 7 on a front side of the infusion assembly 2. However,such a ledge R typically extends at two locations opposing each other onopposite sides of the syringe S, with a rearward ledge hidden behind thebody of this syringe S, but having a similar form to that of the ledge Ron the front side that is shown in FIGS. 1, 4 and 7.

The distal aspect of At least one of these ledges R on the syringe Sprovides an abutment surface for the proximal end of the clamp 30 so asto prevent translation of the infusion device 10 proximal to the syringeS and although not shown in the figure, an additional abutment surfaceattached to the body 21 and abutting upon the proximal aspect of theledge R could be added to reduce translation of the infusion device 10distal to the syringe S. With such an interface against the ledge R, itis not strictly necessary that the clamp 30 grip the syringe Ssufficiently strongly to prevent translation of the clamp 30 and body 21of the infusion device 10 along a central axis of the infusion devicerelative to the syringe S. Rather, the clamp 30 need merely providesufficient force to keep the infusion device 10 on the syringe S, withthe interface between the proximal end 39 of the clamp 30 and the ledgeR preventing axial translation between the syringe S and the infusiondevice 10.

Thus, the clamping force 30 that must be overcome to snap the clamp 30onto the syringe S (along arrow F of FIG. 1) does not need to be sogreat that it can also act to hold the infusion device 10 withouttranslation relative to the syringe S. Vacuum forces within the chamber20 and acting on the arm 40 can be quite high, and hence forces tendingto translate the infusion device 10 longitudinally relative to thesyringe S can be quite high. Because the clamping force requiresfactoring in of friction between the clamp 30 and the syringe S,clamping forces of the clamp 30 would need to be exceptionally high toalone prevent translation of the infusion device 10 relative to thesyringe S. By having the proximal end 39 of the clamp 30 abut the ledgeR, clamping forces 30 can be kept at a relatively low level so that evena medical professional with limited strength can easily attach anddetach the infusion device 10 onto and off of the syringe S.

With continuing reference to FIGS. 1, 4 and 7, details of the arm 40 andassociated driver 50 of the infusion device 10 are described, accordingto this preferred embodiment. The arm 40 provides the preferred form ofinterconnection between a sliding sealed piston 42 which slides withinthe chamber 20 and a driver 50 which is a preferred form of interfacewith the plunger P of the syringe S. This arm 40 is preferably anelongate substantially rigid structure sized to reside within thechamber 20 and reciprocate (translate axially) within the chamber 20along a central axis thereof.

The sliding sealed piston 42 is provided at a distal end of the arm 40.This sliding sealed piston 42 is similar to the piston J of the syringeS, and is configured to have a friction fit against interior walls ofthe chamber 20, and formed with a sufficiently rigid material so that afluid-tight fit is provided between the sliding sealed piston 42 andwalls of the chamber 20. Thus, as the arm 40 reciprocates into and outof the chamber 20, the sliding sealed piston 42 also moves within thechamber 20 and a volume of a vacuum space between the sliding sealedpiston 42 and the distal end 22 within the chamber 20 is caused toincrease and decrease in size.

A preferred embodiment of the infusion device includes the slidingsealed piston 42 coupled to a free end 44 of the arm 40 which extendsmost deeply into the chamber 20. This free end 44 preferably isconfigured with a neck 45 defining a portion of the arm 40 which has aslightly smaller cross-sectional diameter than other portions of the arm40. This cross-sectional diameter is preferably also circular in form,but also could have other shapes and still function as the neck 45provided that it is either smaller in size or closer to round than otherportions of the arm 40.

The arm 40 extends proximally away from the free end 44, the neck 45preferably transitions into series of facets 46 which provide the arm 40with a cross-sectional shape which remains constant but which is facetedrather than circular in form. These facets 46 can take on a variety ofdifferent configurations including convex and concave angles. In asimplest form of the invention, four similarly sized facets are providedso that the arm 40 has a generally square cross-section.

This contour for the cross-sectional shape of the arm 40 is similar tothat of the faceted alignment guide 28 of the chamber 20. Thus, the arm40 can translate through the faceted alignment guide 28, but the arm 40is prevented from rotating relative to the faceted alignment guide 28.However, when the neck 45 portion of the arm 40 is aligned with thefaceted alignment guide 28, such rotational restriction is eliminatedand the arm 40, sliding sealed piston 42, as well as the driver 50 canbe rotated as a unit relative to the chamber 20, body 21 and clamp 30(arrow G of FIGS. 4 and 15). When the arm 40 is moved so that it is notaligned with its neck 45 portion adjacent the faceted alignment guide28, then the faceted portion 46 of the arm 40 will be mated with (andcooperating with) the faceted alignment guide 28. This will tend to keepthe arm 40 highly stable and precisely aligned along a central axis ofthe chamber 20 so that the driver 50 will remain precisely aligned withthe proximal terminus H of the plunger P of this syringe S, to providethe infusion device 10 as a very stable force applying means, acting onthe syringe S for infusion therefrom (along arrow K of FIGS. 7 and 16).The force that the infusion device applies during incursion (translationinward), to the syringe proximal terminus, will be translated to actualwork performed on the syringe plunger as the plunger moves inwardcausing infusion of medicament.

An end of the arm 40 opposite the free end 44 includes a bend 48 thereonwhich transitions into the driver 50. The driver 50 is an extension ortransition of the arm 40 which includes a handle 58 and a thrust area52, 54. The thrust area 52, 54 can interface with and thrust theproximal terminus H of the plunger P of the syringe S to cause infusion.In a preferred form of the invention, the driver 50 thrust area 52, 54includes an engagement plate 52 and associated rim 54. The engagementplate 52 is generally planar and oriented perpendicular to the centralaxis of the chamber 20. This plate 52 preferably includes a cylindricalrim 54 extending distally from a perimeter of the plate 52. This rim 54has a diameter slightly greater than the proximal terminus H of theplunger P of the syringe S, with the proximal terminus H typically beingsubstantially round. Thus, when the proximal terminus H is adjacent theengagement plate 52, the rim 54 keeps the driver 50 aligned with theproximal terminus H to further assist in stabilizing the assembly of theinfusion device 10 clamped to the syringe S. The rim 54 may not need toencompass the entire perimeter, but only a portion adequate to resistany movement of the proximal terminus H.

In FIGS. 1, 4, 7, 14, 15, 16, 17 and 18 a transverse member 56 extendsfrom the bend 48 to a rear side of the plate 52 to interconnect theengagement plate 52 to the arm 40. This transverse member 56 preferablyfurther bends to form a hook 58. Such a hook 58 can be utilized tosuspend the entire infusion assembly 2, or at least the infusion device10 and associated syringe S from an elevated support, if desired. Insuch an arrangement, the hook 58 would end up being the highest portionof the entire infusion assembly 2. This hook 58, also acts as a handle58 which can be gripped by a user for pulling of the driver 50, arm 40and sliding sealed piston 42 (along arrow E of FIGS. 4 and 14) againstthe resistance force (which in this embodiment includes the slidingsealed piston forced distally by the vacuum force) and for ease inrotation of the same structures (along arrow G of FIGS. 4 and 15). Anembodiment shown in FIG. 21 demonstrates an alternate, but equivalentlydesirable design for the driver 50, handle 58 and thrust area 52, 54. Inthis embodiment the thrust area with the plate 52 and rim 54 are affixedto the distal most aspect of the handle 58, leaving a loop rather than ahook, when the infusion device 10 is actively engaged with the syringeS.

The driver 50 and arm 40 act as a preferred form of force applicationmember (force applicator) to apply a linear force on the plunger P ofthe syringe S. In this embodiment, the driver 50 is caused to move byaction of the arm 40 and the sliding sealed piston 42 being drawn intothe vacuum between the sliding sealed piston 42 and the distal end 22within the chamber 20. Provided that a pure vacuum exists between thesliding sealed piston 42 and the distal end 22 of the chamber 20, thisforce remains entirely constant and is proportionate to the atmosphericpressure outside of the vacuum chamber 20. Thus, a constant force isapplied to the syringe S for discharge of medicament over the entirelength of force applicator incursion.

In alternative embodiments, the vacuum chamber 20 can be replaced withsome other form of energy storage and resistance force applicationprinciple (resistance force energizer). For instance, a tension springcould be placed between the driver 40 and a surface generally attachedto the body 21. The spring would tend to hold the force applicator (arm40 and driver 50) at its resting point (maximum incursion) until theuser applies energy to produce excursion of the force applicator 40, 50,thereby stretching the tension spring and activating the infuser. Thespring would then exert a force tending to return the force applicator40, 50 back to its resting point, thereby inducing forced incursion(inward movement) of the driver 50 which would perform useful work onthe syringe plunger P. Simultaneously, the driver 50 could supply thisforce to the plunger P of the syringe S.

As another alternative, the infusion device body 21 could contain acompressed gas chamber rather than a vacuum chamber 20. Such acompressed gas chamber would typically be located on the proximal sideof the sliding sealed piston 42, between the sliding sealed piston 42and the ported base 26. This would require a fluid tight seal on theproximal aspect of the chamber near the ported base 26 and alignmentguide 28. Another compressed gas force energizer could include acompressed air cartridge removably attachable to such a compressed gasreservoir and provide a force proportionate to the difference betweenthe pressure within the compressed air source and atmospheric pressure.If this compressed air supply is sufficiently high in pressure, as thedriver 50 would move, along with any sliding sealed piston 42 coupledthereto, the pressure differential would reduce slightly relative toatmospheric pressure but would be sufficiently small that asubstantially constant force would be applied to the syringe S. Otheranalogous alternative resistance force energizers could also beprovided.

The resistance force energizers (vacuum chamber 20, spring, compressedgas, etc.) will tend to hold the force applicator 40, 50 at its restingpoint, but can also act as an energy storage device when the forceapplicator (arm 40 and driver 50) section is locked out in some degreeof excursion and temporarily held there by an interaction between thearm 40 and the infusion device base 26. In the preferred embodiment,such locking of the arm 40 relative to the base 26, through interactionof the facets 46 on the arm 40 with the faceted alignment guide 28 ofthe body 21 causes potential energy to be stored equivalent to theresistant force that is applied to the arm 40 multiplied by the distancethat the force applicator (arm 40 and driver 50) and sliding sealedpiston 42 have been translated outward (excursion). In the case of aspring, the potential energy is the distance traveled by the spring whenthe arm 40 or similar structure is able to move, multiplied by thespring force for the spring.

With particular reference to FIGS. 2, 3, 5, 6, 8 and 9, details of thestopcock valve 60 according to a preferred embodiment are described. Insome of these embodiments (FIGS. 2, 5 and 8), a manifold hub 70 isprovided according to the most preferred embodiment. In other figures(FIGS. 3, 6 and 9) an alternative manifold hub 170 is provided. For eachof these stopcock valves 60, a common housing 62 is provided.

This housing 62 is generally a short hollow cylinder in form which isopen on one side so that it has a recess 64 therein which is generallycylindrical and generally with a diameter greater than a depth thereof.This recess 64 has its periphery defined by a wall of the housing 62which is generally cylindrical and includes the ports A, B, C, Dtherein, preferably each in a common plane spaced 90° away from eachother and extending radially away from a central axis of the housing 62.

As an alternative, only three ports could be provided (one for a sourceof medicament, such as the second syringe T or vial adapter 90, one forthe syringe S and one for the patient infusion interface 84).Preferably, the ports A, B, C, D are generally cylindrical in form withcentral axes thereof extending radially away from a central axis of thehousing 62 and with the ports A, B, C, D and housing 62 all formedtogether or rigidly attached together as a single construct.

The manifold hub 70 resides within the recess 64 and provides for fluidaccess between at least two of the ports A, B, C, D depending on theorientation of the manifold hub 70 within the recess 64. This manifoldhub 70 is preferably substantially cylindrical in form and has a sizeand shape which allows it to fit snugly within the recess 64, but withrotation allowed about a central axis of the housing 62 (along arrow Iof FIGS. 2-10). This manifold hub 70 includes a selector 72 in the formof an arm which is preferably raised from a face 73 and extends beyond aperimeter of the manifold hub 70. The selector 72 can be graspedmanually and turned to set the valve 60 as desired.

The manifold hub 70 can be hollow or solid but is particularlycharacterized by one or more fluid flow paths contained therein. Mostpreferably, the manifold hub 70 includes a central fluid flow path 74which extends linearly and radially through the manifold hub 70, so thatit can align ports A, C or ports B, D which are opposite each otherdirectly together when the central fluid flow path 74 is aligned withsuch ports A, C or ports B, D.

However, in a most preferred embodiment, the tolerances followed informing the manifold hub 70 and the housing 62 are preferablysufficiently tight that the manifold hub 70 is prevented fromundesirable rotation within the housing 62, and also a fluid tight fitis accomplished. Other techniques for leak prevention or mitigation canalso be utilized, as is known in the art, for such valves.

In the manifold hub 70, a preferred orientation of additional fluid flowpaths demonstrates a first side leg 76 and a second side leg 78 are alsoprovided which extend radially from a center of the manifold hub 70 andat angles 90° spaced from each other and 45° spaced from ends of thecentral fluid flow path 74. With such a configuration, the first sideleg 76 and second side leg 78 can be aligned with adjacent ports A, B,C, D for passage of fluid between any two adjacent ports A, B, C, Ddepending on the position of the manifold hub 70, as controlled bygripping and rotation of the selector 72 (along arrow I).

With particular reference to FIGS. 3, 6 and 9-13, details of analternative manifold hub 170 are described. This alternative manifoldhub 170 is preferably similar to the manifold hub 70 except that fluidfluid flow paths therein are routed somewhat differently. In particular,a selector 172 and face 173 are similar to those of the manifold hub 70.A first fluid flow path 174 is provided which is linear and extendsradially through a middle of the alternative manifold hub 170 with nointersections at midpoints thereof. A second fluid flow path 176 is alsoprovided which is positioned lateral and parallel with the first fluidflow path 174, but is laterally spaced from the first conduit 174. Aversion of the second flow path 176, which is not shown, may be nonlinear and skirting along the periphery of the manifold hub 170, buthaving openings on each side that would coincide with those shown on thesecond fluid flow path 176. Sleeves 175 can be provided as depicted inFIG. 11.

The second fluid flow path 176 is positioned so that ends thereof arespaced 45° away from ends of the first fluid flow path 174. Thus, endsof the first fluid flow path 174 and second fluid flow path 176 aresimilarly placed as ends of the central fluid flow path 74 and legs 76,78 of the manifold hub 70 (FIGS. 2, 5 and 8). By rotation of themanifold hub 70, 170 relative to the housing 62 (along arrow I of FIGS.2-10), ends of the fluid flow paths 74, 76, 78, 174, 176 can be broughtinto alignment with various different ports A, B, C, D to route medicalpreparations or other fluids through the stopcock valve 60 in a mannerdesired.

Preferably, the face 73 is printed with indicia which provide anindication as to where these fluid flow paths are within the manifoldhub 70, 170. Preferably, the selector 72 is provided extending radiallyat a location spaced from this indicia so that the selector 72 does notblock the indicia from being easily viewed by a user. A user merelyorients the indicia so that they are aligned with the ports A, B, C, Dwhich the user desires to have brought together into fluidcommunication, and then the manifold hub 70, 170 is set properly forproper operation of the stopcock valve 60. Such indicia are also usefulin allowing a medical professional to, at a quick glance, verify thatthe stopcock valve 60 is set at the proper position, such as wheninspecting a patient's care regimen.

In use and operation, and with particular reference to FIGS. 14-18,details of the operation of the infusion device 10 are described,according to a preferred embodiment. Initially, a user has the option offirst snapping the infusion device 10 onto the syringe S (arrow F ofFIG. 1) or first charging the chamber 20 with a vacuum by excursion(movement of the driver 50, arm 40 and associated sliding sealed piston42 proximally out of the chamber 20) of the force applicator via itshandle 58, as shown in FIG. 14. Upon such movement, a vacuum is drawnwithin the chamber 20 and potential energy is induced, yielding a stateof “activation.” If some time will elapse before the infusion device 10will be utilized or if a pause is required, the force applicator may bereversibly disabled while in this activated state. This disablingrequires the handle 58 of the driver 50 to be rotated (arrow G of FIGS.4 and 15) so that the facets 46 on the arm 40 no longer are aligned withthe facets on the faceted alignment guide 28. Thus, when the handle 58of the driver 50 is released, and the vacuum pulls (actually theatmosphere pushes) the arm 40 toward the vacuum chamber 20 distally, thefacets 46 on the arm 40 abut the faceted alignment guide 28 in thisnonaligned disabling configuration to prevent further movement of thearm 40 into the chamber 20. This activated but disabled configurationallows the device to store the potential energy. Other potentialmechanisms exist for disabling the force applicator while activatedincluding a pin or sliding plate that could be reversibly attached tothe arm at various positions but not being able to traverse through thealignment guide, thereby halting incursion of the arm and infusion.

By providing four facets 46 on the arm 40 and four facets on the facetedalignment guide 28, and a generally square cross-section for each,rotation of the arm 40 (along arrow G) 45° from the disabledconfiguration about a central axis thereof will cause the infusiondevice 10 to transition back from a disabled potential energy storageorientation to an enabled energy delivering force applicator (and viceversa).

Such rotation of the arm 40 (about arrow G of FIGS. 4 and 15), can bothbe used to put the infusion device 10 into a potential energy storageorientation, but also can be utilized to provide clear access to theplunger P of the syringe S or to engage the driver 50 of the infusiondevice 10 with the proximal terminus H of the plunger P of the syringeS. For instance, after the infusion device 10 has been snapped on to thesyringe S (arrow F of FIG. 1) and after a vacuum has been drawn on thechamber 20 (by movement along arrow E of FIGS. 4 and 14) and after thearm 40 has been rotated slightly (about arrow G of FIG. 15) while theneck 45 of the arm 40 is aligned with the faceted alignment guide 28, sothat the infusion device 10 is in a potential energy storageorientation, the piston P of the syringe S can still be easily accessed.In such an orientation, a user can load the syringe S in a typicalfashion, such as by pulling on the proximal terminus H of the plunger Pto cause medicament to be drawn into the syringe. Such a loading of thesyringe S can occur with medicament being supplied from another syringesuch as the second syringe T, or from a medication vial M, or from someother source coupled to the stopcock valve 60 through one of the portsA, B, C, D. As another alternative, the syringe S could be a preloadedsyringe or it could be loaded from a proximal end, or it could beremoved from the stopcock valve 60 altogether and loaded in some otherfashion.

Once the syringe S has been loaded and is ready for infusion, the arm 40is further rotated so that the driver 50 can be aligned with theproximal terminus H of the plunger P of the syringe S. The driver 50 isthen released slightly until the engagement plate 52 abuts the proximalterminus H of the syringe S. Force is now being applied to the plunger Pof the syringe S and medicament is being delivered from the syringe Sand through the stopcock valve 60 and into the patient through thepatient interface section and its connector 84.

The stopcock valve 60 would first be rotated appropriately (along arrowI) so that fluid flow would occur toward the patient interface section80, 82, 84. Such force application occurs along arrow K of FIGS. 7 and16. Because the force occurs at a constant rate, as the force associatedwith the vacuum remains constant, a constant force is applied to thesyringe S for delivery of the medicament at a constant rate. This forcecan be modified by modifying a volume of the chamber 20, such as bymodifying a diameter of the chamber 20. Thus, different size infusiondevices could be provided having different forces and hence differentflow rates. As another alternative, the regulator 80 can be utilized forsuch flow rate regulation. Other flow restrictions at other locations,including at an interface between the syringe S and the stopcock valve60 or as a function of the tubing itself could also alternatively beutilized for such infusion rate control.

If a user desires to provide an additional surge of medical preparationinto the patient through the patient interface 80, 82, 84, a medicalprofessional can merely push on the handle 58 of the driver 50 toenhance the force that is otherwise being provided by the interaction ofthe atmosphere and the vacuum chamber 20 (or they could change the flowdirection through the stopcock valve 60 to exit another port with adecreased or absent flow regulator 80). Similarly, infusion can betemporarily or permanently stopped by merely pulling on the handle 58 ofthe driver 50 (along arrow B of FIG. 14) in the middle of an infusionprocess to pull the driver 50 off of the proximal terminus H of theplunger P of the syringe S, until the neck 45 of the arm 40 is alignedwith the faceted alignment guide 28. Then, the force activator with itsarm 40 can be rotated slightly (along arrow G) to cause energy storageonce again. The syringe S will then sit idle and disabled with nomedicament infusing until the infusion device 10 is again positionedwith the driver 50 acting on the proximal terminus H of the plunger P ofthe syringe S. Thus for instance, if the patient interface 80, 82, 84requires adjustment, the infusion device 10 can be easily stopped andrestarted in the midst of infusion. The infusion process may also bereadily discontinued by truly deactivating the force activator. Thisdeactivation discontinues infusion as well and is accomplished bypulling the force activator back to its neck, rotating it (and its arm40) a full 90° or 180° in either direction to another correspondingfaceted position (where the faceted arm may again undergo incursionthrough the faceted alignment guide, but with incursion occurring wherethe engagement plate will not interact with the syringe proximalterminus) where the force activator can be let down to its resting pointthereby releasing the stored potential energy and stopping the infusionprocess.

FIG. 22 demonstrates an infusion syringe S “built in” to a typicaldisposable intravenous (IV) administration set. The syringe S is placedproximally in the set in an “inline” configuration and in thisembodiment also takes the place of the “drip chamber” which is typicallypresent in the prior art administration sets.

The FIG. 22 preferred embodiment shown demonstrates the IV fluid flowpath which would deliver the IV fluid from a plastic bag into thestopcock (not shown, but from stopcock port A to port C) and into thesyringe S via the port at the distal tip (stopcock port C wouldtypically be directly connected to the port at the syringe distal tip,but for clarity, it is shown adjacent in this figure). The IV fluidwould enter the syringe tip through an embedded “drip needle” 101, sothat dripping IV fluid 102 could be visualized and quantified bycounting drips per minute as it drips into the medicament reservoir 104.The IV fluid or medicament in the medicament reservoir 104 exits via asecond port called the piston fluid conveyance port 105 (positioned onthe syringe piston J and allowing fluid conveyance through the piston Jand into the IV fluid tubing 106 where it may traverse down along thesyringe plunger P (or within the plunger P) through further IV fluidtubing 106 and eventually into the patient's vein). This embodimentwould save the practitioner the trouble of locating a separate syringefor medicament delivery as it would already be present in the IVadministration set where it could be utilized in similar fashion todescriptions of this invention noted elsewhere in this disclosure.

With reference to FIGS. 23-33, details of a specific embodiment of theinfuser 410 of this invention are disclosed along with an exemplarysyringe S in practicing the system and method of this invention.Referring to FIG. 23 primarily, an infuser 410 is depicted whichincludes a chamber 420 in which a vacuum can be drawn. A piston 442translates within the chamber 420 and is coupled to an arm 440 whichextends out of the chamber 420. A driver 450 is located on an end of thearm 440 opposite the piston 442. A clamp 430 assembly is located closerto a distal end of the chamber 420 with a retainer 460 located closer toa proximal end of the chamber 420. The clamp 430 assembly and retainer460 act together to removably couple the infuser 410 to a syringe S.

The clamp 430 assembly preferably has multiple stations which cansupport a separate syringe S. Each station preferably includes a clamp430 which is sized to allow an outlet end of the syringe S to snapthereinto. A boss 470 is preferably located adjacent each clamp 430 withthe boss 470 sized similar to the outer periphery of the outlet of thesyringe. In this way, a clamp 430 can either snap onto an outlet 485 endof the syringe S or onto a boss 470 of an additional infuser 410 (seefor instance FIG. 32).

The retainer 460 also includes multiple stations with a number ofstations provided on the retainer 460 generally corresponding with thenumber of stations provided on the clamp 430 assembly and with suchretainer 460 stations aligned with the clamp 430 stations. Each retainer460 station has a semi-circular saddle which can cradle a portion of thecylinder 486 of the syringe S therein adjacent to a flange 487 of thesyringe S.

The flange 487 of the syringe S preferably includes holes 488 thereinwhich are sized and spaced from each other a distance similar to adistance between prongs 465 on the retainer 460 associated with eachstation and near ends of the saddle. The prongs 465 can reside withinthe holes 488 so that the flange 487 of the syringe S is held securelyto the infuser 410. A side of the retainer 460 opposite the prongs 465preferably includes a series of bores 467 therein which are spaced aparta distance similar to a distance between the prongs 465. In such anarrangement, the prongs 465 can optionally reside within bores 467 of anadjacent separate infuser 410 (see for instance FIG. 32) to allow twoinfusers 410 to be attached together.

The arm 440 and driver 450 of the infuser 410 are adapted to translaterelative to remaining portions of the infuser 410 with the driver 450able to engage with a proximal end of a plunger P of the syringe S toapply a force on the plunger P tending to drive fluid out of the outlet485 of the syringe S. A passage through the retainer 460 allows the arm440 to pass therethrough in a manner that allows translation of the arm440 but resists rotation of the arm 440. The arm 440 has a contour whichmatches the contour of this passage through the retainer 460 except at asection on the arm 440, preferably near the piston 442, where the arm440 has a differing cross-section which facilitates rotation of the arm440. The particular geometry for such structures is depicted in FIG. 23.

FIGS. 24-28 reveal a series of steps associated with aligning the arm440 and driver 450 of the infuser 410 with the plunger P of the syringeS and acting over time to efflux fluid out of the outlet 485 of thesyringe S as the piston 442 is drawn into the chamber 420 of the infuser410 to replace the vacuum contained therein. FIG. 29 is an explodedparts view of that which is shown in FIGS. 23-28.

The piston 442 preferably has a specific configuration such as thatdepicted in FIGS. 30 and 31. The piston 442 is preferably fitted with aseries of O-ring 444 type seals which are biased. With such a bias, airis allowed to pass more readily past the piston 442 and toward the arm440 than past the piston 442 and away from the arm 440. With such abiased configuration for the O-rings 444, the piston 442 and associatedarm 440 can be readily inserted into the chamber 420 during initialassembly without compressing air against the distal end of the housing.As the piston 442 is initially driven into the chamber 420, airoriginally within the chamber 420 is able to pass the biased O-rings 444to exit the chamber 420. Once the piston 442 has been driven all the wayto the distal end of the chamber 420, the infuser 410 is then in aconfiguration ready for operation. When the piston 442 is latertranslated toward the proximal end of the chamber 420 and away from thedistal end of the chamber 420, air cannot pass the biased O-rings 444 sothat a vacuum is drawn within the chamber 420 at the distal end thereof.Such a piston 442 with biased O-rings 444 eliminates the need for a portat the distal end of the chamber 420 for initial piston 442 positioning.

With particular reference to FIG. 32, an assembly is depicted whichutilizes a pair of infusers 410 and a pair of syringes S. The twoinfusers 410 have been coupled together utilizing the clamps 430 andbosses 470 of the clamp 430 assemblies and the prongs 465 and bores 467of the retainers 460. Each infuser 410 is also coupled to a syringe S inthe manner depicted in FIGS. 23-28. Such interconnection of the infusers410 can be useful where more than one medication is to be infusedsimultaneously, so that separate syringes S are provided with separatemedications. With the infusers 410 able to be coupled together, a singleassembly is provided for delivery of two or more such medications.

Furthermore, and with reference to FIGS. 23-28, it can be seen thatpreferably at least two stations are provided on each clamp 430 assemblyand each retainer 460. Hence, two syringes S can be coupled to a singleinfuser 410. According to one use of the infuser 410 of this invention,two syringes S loaded with medication can be coupled to separatestations on the infuser 410. The infuser 410 can be set to begininfusing from one syringe S. When medication within the first syringe Shas been entirely dispensed, the infuser 410 can be recharged by pullingthe piston 442 and arm 440 out of the chamber 420 and rotating the armso that the driver 450 is aligned with the second syringe S and thenmedication from the second syringe S can be dispensed. Thus, a potentialfor an overall singular assembly which has twice the capacity isfacilitated. If three or more stations are provided on the clamp 430assembly and retainer 460 of each infuser 410, three or more syringes Scan be included in such an overall assembly. With reference to FIG. 33,an infuser 510 is depicted which exhibits three such stations on a clamp530 assembly and on a retainer 560 to illustrate how such amulti-station infuser 510 could be configured according to thisembodiment.

While the infuser 410 is depicted with a vacuum chamber 420, as analternative a spring could be interposed between the arm 440 of theinfuser 410 and the chamber 420 or infuser body replacing such a chamber420. In one embodiment this spring could be a helical compression springlocated within the chamber and generally between the proximal side ofthe piston 442 and the retainer 460. The chamber 420 could still beprovided to allow the spring to operate within a controlled environment.Similarly, a helical tension spring could be interposed between a distalend of the arm 440 and a distal end of the chamber 420, or other distalend of the infuser 410.

With particular reference to FIG. 36 details of a torsion power springdriven infuser 610 are described, according to an alternativeembodiment. The torsion power spring driven infuser 610 includes atorsion spring 662 mounted about a central shaft which also acts as aspool 664 upon which a cable 660 can be gathered. This cable 660 extendsfrom the shaft and associated spool 664 at a distal end to an arm 640attachment point at a proximal end. The torsion power spring 662 exertsa rotative force upon the shaft tending to cause the shaft to rotate andfor portions of the cable 660 to be gathered upon the spool 664. Inturn, this tension on the cable 660 causes an energizing tension forceto be maintained on the arm 640 which in turn causes the driver 650 toact upon a plunger of the syringe S to drive the plunger into thesyringe S and deliver fluid out of the syringe S.

The torsion power spring 662 is caused to have energy stored and thespring 662 to be wound by having the arm 640 and driver 650 pulled awayfrom the torsion spring 662. This energy can be stored on the spring 662until needed. Then, when the driver 650 is coupled to a plunger of thesyringe S and the arm 640 released from any engagement structures whichlock the arm 640 in position, the arm 640 is caused to be drawn towardsthe central shaft of the torsion spring 662 to provide the infusionforce. An infusion rate is provided which correlates with a spring forceof the torsion spring 662 and to resistance to fluid flow associatedwith the syringe S and downstream structures such as microbore tubing,flow rate control elements and any friction built into the system.

The holes 488 in the flange 487 of the syringe S are preferablyconfigured to match an arrangement of prongs 465 on the retainer 460 ofthe infuser 410. Such coordination of holes 488 and prongs 465 caninclude the position of the holes 488 and prongs 465, the number ofholes 488 and prongs 465, and the location of the holes 488 and prongs465. In addition to stabilizing the syringe S relative to the infuser410, such a particular configuration for the holes 488 and prongs 465can act to coordinate syringes S of a particular style with infusers 410of a particular style. For instance, infusers 410 having different ratesof infusion and different amounts of force applied can be produced, suchas by changing a diameter of the chamber 420. Different medications havedifferent desired rates of infusion. Syringes S preloaded with amedication having a desired rate of typical infusion could be configuredwith a hole 488 pattern on the flange 487 which would correspond withthe prong 465 pattern on an infuser 410 which provides the desiredinfusion rate. Such coordination assists a user in matching a properinfuser 410 with the proper syringe S and medication.

While the holes 488 and prongs 465 are shown on the flange 487 andretainer 460 respectively, the prongs 465 could be provided on theflange 460 of the syringe S and holes 488 provided on the retainer 460.While the prongs 465 and holes 488 are each shown with a circularcross-section they could have differing shapes which would not fitunless the proper syringe S is mated with the proper infuser 410.Furthermore, even with standard syringes S and infusers 410 it isdesirable that the holes 488 and prongs 465 act together to securelyhold the flange 487 of the syringe S adjacent the infuser 410. Bymatching configurations of the prongs 465 and holes 488, a qualitycontrol feature is also provided in that syringes S and infusers 410which have been manufactured to the desired quality standards interfacetogether while syringes S and infusers 410 of differing qualitystandards and without the authorized prong 465 and hole 488configuration would not match together, such that the qualityexpectations of the user can be met.

With reference to FIG. 34, details of an alternative embodiment gasdriven infuser 710 are described. With this gas driven infuser 710, thechamber is fitted with a piston 742 with associated arm. However, adistal end of the chamber 720 is not sealed and not configured tocontain a vacuum. Rather, a proximal end of the chamber 720 is enclosedand has a feed line 762 associated therewith which leads to a controlvalve 764 to which a CO₂ gas cartridge 766 or other gas cartridge 766can be attached. Typically this cartridge 766 is removably attached tothe control valve 764. One configuration could be similar to thatutilized in paintball marker compressed CO₂ gas firearms.

The control valve 764 acts as a regulator which can selectively allowcompressed gas to pass into the housing 720 through the feed line 762.Through calibration and control of design details such as a friction ofthe piston 742 as it slides within the housing 720, and an amount ofresistance to flow associated with an outlet of the syringe S and/ordownstream resistance such as within microbore tubing or other flowrestriction devices, a rate at which the gas driven infuser 710 operatescan be controlled.

As an alternative, a more active control can be utilized which causesthe control valve 764 to open and close appropriately depending onwhether a rate of infusion is faster or slower than a desired rate. Sucha basic control system would keep track of a position of the plungerwithin the syringe S and keep track of time and increase or decreaseopenness of the control valve 764 depending on whether a sensed rate ofinfusion is faster or slower than a desired rate.

A bleed port would typically be built into the control valve 764 whichwould allow for the piston 742 to return to a proximal end of thehousing 720, such as after infusion of fluid from the syringe S has beencompleted and it is desired to reset the infuser 710 with a new loadedsyringe S. One advantage of such a gas driven infuser 710 would be itsability to operate consistently in environments having differentpressures, such as at different altitudes within Earth's atmosphere orpotentially underwater or in space where pressures radically divergingfrom atmospheric pressure are experienced.

With particular reference to FIG. 35 details of a motorized infuser 810embodiment of this invention are described. With the motorized infuser810, a housing which would otherwise have been filled with gas (orcontaining a vacuum) is fitted with a motor 860, such as at a distalend, with a rotating output shaft. This rotating output shaft ispreferably coupled to an elongate threaded shaft 864. A threaded nut 862is configured to ride along this threaded shaft 864 with threads whichmate with the threaded shaft 864 to cause the nut 862 to translate whenthe threaded shaft 864 rotates. An arm 840 of the infuser 810 is coupledto the nut 862 (with portions of this arm 840 cut away in FIG. 15 toreveal details of the threaded shaft 864).

A driver 850 is coupled to the arm 840 and acts upon a plunger of thesyringe S. Thus, when the motor 860 rotates, the threaded shaft 864rotates, causing the nut 862 to translate and the arm 840 coupled to thenut 862 is also caused to translate so that the driver 850 acts on theplunger of the syringe S to infuse fluid from the syringe S. Typically,some form of guide is provided on the nut 862 to keep the nut 862 fromrotating with the threaded shaft 864, so that the nut 862 is required totranslate when the threaded shaft 864 rotates.

A controller would be provided for the motor 860 which would keep trackof a rate of rotation and match a rate of rotation and a rate oftranslation of the nut 862 to match a rate of infusion desired for thesyringe S. Such a controller could be adjustable with inputs to allowmedical professionals to set and adjust a rate of infusion associatedwith the motor 860. The motor 860 would also require some form of powersource to provide motive force for operation of the motor 860. Such apower source could be batteries, a self contained power source such asfuel cells or solar panels, or could be an electric cord which can pluginto available standard electric service.

Other forms of springs or resilient members could also be interposedbetween the arm 440 and other portions of the infuser 410 to provide theresistance force energizer of this invention to cause the driver 450 toapply forces on the plunger P of the syringe S.

This disclosure is provided to reveal a preferred embodiment of theinvention and a best mode for practicing the invention. Having thusdescribed the invention in this way, it should be apparent that variousdifferent modifications can be made to the preferred embodiment withoutdeparting from the scope and spirit of this invention disclosure. Whenstructures are identified as a means to perform a function, theidentification is intended to include all structures which can performthe function specified. When structures of this invention are identifiedas being coupled together, such language should be interpreted broadlyto include the structures being coupled directly together or coupledtogether through intervening structures. Such coupling could bepermanent or temporary and either in a rigid fashion or in a fashionwhich allows pivoting, sliding or other relative motion while stillproviding some form of attachment, unless specifically restricted.

What is claimed is:
 1. A non-electric system for medicament infusion,the system comprising: at least one infusion device adapted to becoupled lateral to at least one medicament syringe; said medicamentsyringe including a cylinder and an elongate plunger assembly, saidassembly comprised of an actuating rod with a distally positioned pistonopposite a proximal terminus, said piston adapted to sealingly slidewithin said cylinder, said cylinder including a distal cylinder portionpositioned distal to said piston, said distal cylinder capable ofcontaining medicament and having at least one fluid conveyance portcommunicating with said distal cylinder portion; said infusion devicecomprising a body, a resistance force energizer, and a force applicator,said force applicator including a reciprocating arm with a driver at aproximal end, said resistance force energizer applying a force betweensaid body and said force applicator to move said force applicator towarda resting point; said driver including a thrust surface and a handle,said handle adapted for manual excursion of said force applicatoragainst said resistance force energizer and away from said resting pointof said force applicator, said excursion requiring manual input ofenergy to overcome said force applied by said resistance forceenergizer; said driver adapted to be selectively engaged or disengagedwith said syringe proximal terminus at said driver thrust surface; andsaid driver, when engaged with said syringe proximal terminus, adaptedto transfer forces from said force applicator to said syringe plungerassembly, thereby pushing said syringe piston distally into said syringedistal cylinder portion, forcing medicament efflux through said fluidconveyance port.
 2. The system of claim 1 wherein said medicamentsyringe is coupled to a patient infusion interface, said interfaceincluding a flow regulator and terminal connector, said flow regulatoradapted to influence the rate of medicament flow.
 3. The system of claim2 wherein a fluid control valve with at least two peripheral ports iscoupled between the syringe distal port and said patient infusioninterface, said valve including a generally circular cross sectionalbody having a recess therein with said ports along said peripheryoriented in a common plane and accessing said recess; and a manifold hubrotatably supported within said recess, said manifold hub with fluidflow paths therein, said manifold hub rotatable to selectively connectsaid ports of said valve together through said fluid flow paths.
 4. Thesystem of claim 3 wherein said valve has at least three peripheralports; a first port coupled to said medicament syringe, a second portcoupled to said patient infusion interface, and a third port adapted tobe used for a procedure taken from the group of procedures including:medicament manipulation, secondary syringe placement, medicament vialadaptor placement and medicament infusion.
 5. The system of claim 3wherein said valve includes four ports oriented such that each of saidfour ports are spaced equidistantly along said periphery and whereinsaid manifold hub includes at least two fluid flow paths.
 6. The systemof claim 5 wherein said at least two fluid flow paths include twononintersecting paths with one of said nonintersecting paths passingthrough a center of said manifold hub and the other of said at least twononintersecting paths spaced laterally from said first path.
 7. Thesystem of claim 5 wherein said manifold hub includes a central fluidflow path extending linearly through a center of said manifold hub and apair of side leg fluid flow paths intersecting said central fluid flowpath at a center thereof, each of said side leg fluid flow pathsoriented perpendicular to each other and 45° from said central path. 8.The system of claim 1 wherein said resistance force energizer includes aspring connected to said force applicator.
 9. The system of claim 1wherein said resistance force energizer contains a vacuum chamber, saidvacuum chamber having at least one distal atmospheric port and asealingly slidable piston having a distal side and a proximal side, saiddistal side forming a proximal wall of said vacuum chamber and saidproximal side exposed to the atmosphere and attached to said forceapplicator reciprocating arm, said distal atmospheric port having afluid tight means for closure adapted to open and close said distalatmospheric port; thereby allowing gas evacuation from said vacuumchamber if the vacuum condition has been compromised.
 10. The system ofclaim 1 wherein said resistance force energizer includes a compressedgas source and a sealingly slidable piston attached to said forceapplicator reciprocating arm, said compressed gas applying a gaspressure force on the proximal side of said slidable piston such thatsaid force applicator is induced to move distally causing said incursionof said force applicator by said compressed gas.
 11. The system of claim1 wherein said force applicator is adapted to be reversibly disabled ina state storing said potential energy.
 12. The system of claim 1 whereinsaid force applicator reciprocating arm is oriented to traverse throughan alignment guide provided with said infusion device as said armreciprocates, said arm having long segments thereof with a cross-sectionmatching a corresponding cross-section of said alignment guide therebydisallowing rotation of said force applicator and short segments thereofwhich have a cross-sectional width less than the narrowest width of saidalignment guide thereby allowing rotation of said force applicator, suchthat said arm can be rotated relative to said alignment guide at saidshort segments of said arm and not rotated relative to said alignmentguide at said long segments of said arm.
 13. The system of claim 1wherein said force applicator reciprocating arm is oriented to traversethrough an alignment guide attached to said infusion device body, saidarm including a plurality of facets on portions thereof and saidalignment guide is provided with facets matching and corresponding to across-section of said arm where said facets are located, and with aportion of said arm in the form of a neck having a circularcross-section with a diameter less than a minimum width of saidalignment guide, such that when said cylindrical neck of said arm isaligned with said alignment guide, said arm can rotate freely about along axis thereof, but with said arm only able to translate linearlythrough said alignment guide in some specific rotational orientationswhere said arm facets and said alignment guide facets are matching andcorresponding.
 14. The system of claim 1 wherein said force applicatorreciprocating arm is oriented to traverse through an alignment guideprovided with said infusion device as said arm reciprocates, whereinsaid force applicator arm includes facets thereon and with saidalignment guide having facets matching and mating with a cross-sectionof said arm, said facets of said arm spaced apart by edges, said edgessufficiently wide to resist passage through said alignment guide whensaid edges are rotated out of alignment with facets of said alignmentguide.
 15. The system of claim 14 wherein said arm can be rotated to aholding position where it resists said incursion and stores saidpotential energy and then repositioned to a non-holding position withsaid facets of said arm aligned with facets of said alignment guide toallow said incursion.
 16. The system of claim 1 wherein said driverthrust area includes a plate adapted to engage said syringe proximalterminus, said plate having a distally protruding rim around a portionof its perimeter to encompass a similar portion of said syringe proximalterminus and thereby resist lateral movement of said syringe proximalterminus at said plate.
 17. The system of claim 1 wherein said activatedforce applicator is adapted to undergo said excursion along a pathavoiding said engaged state and to then be rotated to align said engagedstate.
 18. The system of claim 12 wherein said force applicator arm isadapted to undergo said excursion along a said long segment path withsaid driver in a non rotatable but translatable first position whereassaid engaged state is avoided, following which at a position ofsubstantially full excursion said arm is adapted to be rotated at saidshort segment such that said driver rotates about an axis perpendicularto said excursion and into a second position adapted to allow saiddriver to begin said incursion and to become engaged with said syringeproximal terminus, said incursion occurring along said long segment in anon rotatable but translatable said second position, thereby disallowingany rotation of said arm during said incursion.
 19. The infusion deviceof claim 1 wherein said reciprocating arm has faceted sides such thatsaid arm exhibits a faceted cross-section perpendicular to a long axisof said arm, said arm translating through a correspondingly facetedalignment guide affixed to said body of said infusion device, said armincluding at least one neck on a portion thereof, said neck having awidth smaller than the narrowest diameter of said faceted alignmentguide, such that when said neck is aligned with said faceted alignmentguide, said arm can rotate freely, but when said faceted portion of saidarm is adjacent said faceted alignment guide, said arm is restrainedfrom rotation.
 20. The system of claim 1 wherein said infusion devicehas an attachment device useful for attaching said infusion device toliving and inanimate objects.
 21. The system of claim 20 wherein saidattachment device includes a self connecting type strap.
 22. The systemof claim 1 wherein said medicament syringe is removably coupleable tosaid infusion device.
 23. The system of claim 22 wherein said infusiondevice is reusable and said medicament syringe is disposable.
 24. Thesystem of claim 1 wherein said infusion device and said syringe areunified and disposable.
 25. The system of claim 1 wherein saidmedicament syringe is integrated into a standard type disposableintravenous administration set.
 26. The system of claim 25 wherein saidmedicament syringe includes at least two fluid conveyance ports.
 27. Thesystem of claim 26 wherein one of said at least two fluid conveyanceports is positioned on said piston and adapted to allow fluid conveyancethrough said piston.
 28. The system of claim 26 wherein said medicamentsyringe is adapted to act as a drip chamber.
 29. The infusion device ofclaim 1 wherein said infusion device includes a dampening system, saiddampening system including a fluid filled dampening cylinder attachedrigidly and in parallel to said infusion device body and a dampening rodattached rigidly and in parallel to said force applicator, saiddampening cylinder adapted to receive said dampening rod during whichsaid dampening system becomes activated, said activated dampening systemadapted to limit the speed of said incursion thereby limiting the rateof infusion.
 30. The infusion device of claim 1 wherein said infusiondevice includes a dampening system, said dampening system including adampening rod attached rigidly in parallel to said infusion device bodyand a fluid filled dampening cylinder attached rigidly in parallel tosaid force applicator, said dampening cylinder adapted to receive saiddampening rod during which said dampening system becomes activated, saidactivated dampening system adapted to limit the speed of said incursionthereby limiting the rate of infusion.
 31. At least one nonelectricinfusion device removably coupleable to at least one medical syringe,said device adapted to infuse medicament from the syringe, the syringehaving a cylinder with a fluid conveyance port, an open end opposite thefluid conveyance port, an elongate plunger assembly with a distal pistonopposite a proximal terminus, and the piston adapted to sealingly slidewithin the cylinder; the infusion device comprising in combination: abody containing a resistance force energizer; a force applicatorincluding an arm; said arm having a free end adjacent the resistanceforce energizer; said force applicator adapted to be removablycoupleable to the proximal terminus of the syringe at a location spacedfrom said free end of said arm; and said infusion device body having anattached clamp, said clamp having an elongate inside wall with adiameter substantially similar to a diameter of the syringe cylinder,said clamp having an elongate lateral opening between opposite edgessufficiently large to allow said clamp to snap over and surround aportion of the syringe thereby inhibiting syringe rotation or motionperpendicular to the syringe long axis, the syringe including a ledgeadjacent the open end where the cylinder of the syringe exhibitsincreased diameter, said clamp adapted to abut one or more sides of saidledge and hold the syringe from movement along the syringe long axisthereof when the syringe plunger assembly is being moved by the forceapplicator or the fingers of the user and said clamp has been snappedonto the cylinder of the syringe with said clamp abutting the ledge ofthe syringe.
 32. The system of claim 31 wherein said infusion device isreusable and said medicament syringe is disposable.
 33. The infusiondevice of claim 31 wherein said resistance force energizer includes avacuum chamber, said vacuum chamber including a sliding sealed pistonforming a wall of said vacuum chamber, and said free end of said armcoupled to said sliding sealed piston.
 34. The infusion device of claim33 wherein said arm is adapted to be rotated, said arm including a plateon an end thereof opposite said sliding sealed piston, said plateadapted to engage the proximal terminus of the syringe in less than allrotational positions for said arm.
 35. The infusion device of claim 31wherein said arm has faceted sides such that said arm exhibits a facetedcross-section perpendicular to a long axis of said arm, said armtranslating through a correspondingly faceted alignment guide affixed tothe infusion device body, said arm including at least one neck on aportion thereof, said neck having a width smaller than the narrowestdiameter of said faceted alignment guide such that when said neck isaligned with said faceted alignment guide, said arm can rotate freely,but when said faceted portion of said arm is adjacent said facetedalignment guide, said arm is restrained from rotation.
 36. The infusiondevice of claim 34 wherein said plate includes a rim extending from aperiphery thereof, said rim adapted to at least partially surround theproximal terminus of the syringe plunger assembly when the proximalterminus of the syringe is adjacent said plate, such that said rimresists said plunger assembly movement relative to said plate when saidplunger assembly proximal terminus is adjacent said plate.
 37. Theinfusion device of claim 31 wherein said infusion device includes adampening system, said dampening system including a fluid filleddampening cylinder attached rigidly and in parallel to said infusiondevice body and a dampening rod attached rigidly and in parallel to saidforce applicator, said dampening cylinder adapted to receive saiddampening rod during which said dampening system becomes activated, saidactivated dampening system adapted to limit the inward speed of saidforce applicator when coupled to said syringe plunger assembly therebylimiting the rate of infusion.
 38. The infusion device of claim 31wherein said infusion device includes a dampening system, said dampeningsystem including a dampening rod attached rigidly and in parallel tosaid infusion device body and a fluid filled dampening cylinder attachedrigidly and in parallel to said force applicator, said dampeningcylinder adapted to receive said dampening rod during which saiddampening system becomes activated, said activated dampening systemadapted to limit the inward speed of said force applicator when coupledto said syringe plunger assembly thereby limiting the rate of infusion.39. The system of claim 31 wherein said medical syringe is integratedinto a standard type disposable intravenous administration set.
 40. Thesystem of claim 39 wherein said medical syringe includes at least twofluid conveyance ports.
 41. The system of claim 40 wherein one of saidat least two fluid conveyance ports is positioned on said piston andadapted to allow fluid conveyance through said piston.
 42. The system ofclaim 40 wherein said medical syringe is adapted to act as a dripchamber.
 43. The system of claim 41 wherein said medical syringe isadapted to act as a drip chamber.
 44. A system for infusing of fluidfrom a syringe, the syringe having a fluid containing cylinder, anoutlet from the cylinder and a plunger adapted to translate into thecylinder to push fluid from the syringe through the outlet, the systemcomprising in combination: a driver coupled to the plunger; and a springinterposed between said driver and the cylinder of the syringe, suchthat said spring exerts a force on said driver pushing the plunger intothe cylinder to efflux fluid from the outlet of the cylinder of thesyringe.
 45. A system for infusing of fluid from a syringe, the syringehaving a fluid containing cylinder, an outlet from the cylinder and aplunger adapted to translate into the cylinder to push fluid from thesyringe through the outlet, the system comprising in combination: adriver coupled to the plunger; and a resistance force energizerinterposed between said driver and the cylinder of the syringe, suchthat the resistance force energizer exerts a force on said driverpushing the plunger into the cylinder to efflux fluid from the outlet ofthe cylinder of the syringe.
 46. The system of claim 45 wherein saidresistance force energizer includes a spring interposed between saiddriver and the cylinder of the syringe.
 47. The system of claim 45wherein said resistance force energizer includes an elongate vacuumchamber with a movable piston residing therein, an arm coupled to saidpiston, said arm coupled to said driver, said vacuum chamber coupled tothe cylinder of the syringe.
 48. A system for infusing of fluid from asyringe, the syringe having a fluid containing cylinder, an outlet fromthe cylinder and a plunger adapted to translate into the cylinder topush fluid from the syringe through the outlet, the system comprising incombination: a driver coupled to the plunger; and an elongate vacuumchamber with a movable piston residing therein, an arm coupled to saidpiston, said arm coupled to said driver, said vacuum chamber coupled tothe cylinder of the syringe, such that said arm exerts a force on saiddriver pushing the plunger into the cylinder to efflux fluid from theoutlet of the cylinder of the syringe.